A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00300287
First received: March 6, 2006
Last updated: July 16, 2007
Last verified: July 2007
  Purpose

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in HbA1c at 108 weeks

Secondary Outcome Measures:
  • Adverse event profile after 108 weeks of treatment
  • Change in HbA1c from week 52 to week 108
  • Change from baseline in fasting plasma glucose at week 108
  • Change in fasting plasma glucose from week 52 to week 108
  • Change from baseline in body weight at week 108

Estimated Enrollment: 150
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Completion of study CLAF237A2307 within 4 weeks of entering into the extension
  • Written informed consent
  • Ability to comply with all study requirements
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Premature discontinuation from study CLAF237A2307
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300287

Locations
Germany
Investigative Sites, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00300287     History of Changes
Other Study ID Numbers: CLAF237A2307E1
Study First Received: March 6, 2006
Last Updated: July 16, 2007
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Novartis:
Type 2 diabetes
Vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014